Kornimate/medical-research-clean huggingface dataset:
anal dilatation plus probiotics before ileostomy reduction for low anterior resection syndrome

Conditions: Low Anterior Resection Syndrome

Summary: this is randomized, phase 2 trial in patients with rectal cancer undergoing sphincter-preserving proctectomy and temporary ileostomy, to explore the effects of anal dilatation plus probiotics administered per anus before ileostomy reduction in relieving postoperative bowel dysfunction known as low anterior resection syndrome (lars).

approximately 60-90% of patients undergoing sphincter-sparing proctectomy complain of postoperative bowel dysfunction including incontinence, frequency, clustering, and urgency, collectively known as low anterior resection syndrome (lars). literatures and our previous data have demonstrated that diverting ileostomy is an independent risk factor for major lars. this is a randomized, phase 2 trial in patients with rectal cancer who underwent sphincter-preserving proctectomy and ileostomy. this study will explore the effects of anal dilatation plus probiotics administered per anus in relieving the symptoms of lars.

Eligibility criteria:
inclusion criteria: 1. a voluntarily signed and dated informed consent form; 2. ecog performance status is 0 or 1; 3. age at enrollment is of 18 to 80 years old.; 4. r0 sphincter-preserving proctectomy and temporary ileostomy for rectal cancer; 5. the distance from anastomosis to anal verge is ≤7cm; 6. both the anastomosis and the ileostomy is intact at 2 weeks follow-up after proctectomy; 7. baseline lars score before proctectomy is \<30; 8. the preoperatively predicted lars (polars) score after proctectomy is ≥28. exclusion criteria: 1. r1/r2 resection or untreated metastases; 2. any synchronous or metachronous malignancies, except for cancers that have received curative treatment and have not recurred for more than 5 years, or carcinoma in situ that have been cured by appropriate treatment; 3. severe morbidity with life expectancy less than 2 years; 4. any toxicity of ctcae grade 2 or above due to previous treatment that have not resolved, except for anemia, alopecia, skin pigmentation; 5. anastomotic leak within 2 weeks after proctectomy, suspected by clinical symptoms, digital rectal examination, or imaging; 6. complications of the ileostomy within 2 weeks after proctectomy, leading to premature takedown of the stoma (within 2 months after surgery); 7. any medical condition that may affect the safety and compliance of the subject.

Keywords: rectal cancer temporary ileostomy low anterior resection syndrome anal dilatation gut microbiota
denosumab for prolonging bone metastasis-free survival in men with hormone-refractory prostate cancer

Conditions: Castrate-resistant Prostate Cancer

Summary: this is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer. patients currently participating in the phase 3 study 20050147 (nct00286091) will be offered this study if a positive benefit:risk compared with placebo is determined in the 20050147 study. the primary endpoint of the 20050147 study is bone metastases-free survival determined by the time to first occurrence of bone metastases (either symptomatic or asymptomatic) or death from any cause. participants will receive open-label denosumab administered once every 4 weeks (q4w) subcutaneously (sc) until they developed a bone metastasis or for up to 3 years, whichever comes first.


Eligibility criteria:
inclusion criteria: * subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study 20050147 * subjects must sign the informed consent before any study specific procedures are performed exclusion criteria: * developed sensitivity to mammalian cell derived drug products during the 20050147 study * currently receiving any unapproved investigational product other than denosumab * any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
safety and efficacy of marqibo in metastatic malignant uveal melanoma

Conditions: Metastatic Malignant Uveal Melanoma

Summary: marqibo (liposomal vincristine) is a form of vincristine preparation. vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. this may cause the cancer cells to die. liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. the liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously. the goal of this clinical research study is to learn if marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. the safety of liposomal vincristine will also be studied. approximately 50 patients will take part in this study.


Eligibility criteria:
inclusion criteria: * uveal melanoma with histologic or cytologic confirmation of metastatic disease. * one unidimensionally measurable lesion. if this is a cutaneous lesion it must be at least 10 mm by caliper measure. if it is a visceral or nodal or soft tissue lesion, it must be \>20 mm with conventional techniques or \>10 mm with spiral ct scan. bone lesions are not considered measurable. * must not have received any prior systemic chemotherapy, immunotherapy, vaccine or hepatic arterial chemotherapy for metastatic disease. * adequate liver, renal, and bone marrow function. * zubrod performance status of 0-2. * sign an informed consent form. exclusion criteria: * major surgery within 4 weeks of enrollment. * advanced symptomatic central nervous system (cns) involvement by melanoma and those on phenytoin or requiring steroids for brain metastases, spinal cord compression, or meningeal "carcinomatosis". * history of neurological disorders unrelated to chemotherapy (including familial neurological diseases and acquired demyelinating disorders). * grade 2 or greater sensory, motor and/or autonomic neuropathy at screening from any cause. * receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by cytochrome p450-3a4 isoenzymes and/or p-glycoprotein within 1 week of study enrollment.
ventricular assist device (vad) research registry and blood sub-study

Conditions: Heart Failure

Summary: this study is meant to predict the outcome of vad therapy, by forming a vad registry for quality assessment, research, and real-time monitoring of patients on vad therapy. the goal is to optimize the use of vad therapy for patients, to create an online quality measurement tool for vad treatment, and to create algorithms to estimate the prognosis for patients getting a vad.

patients eligible for vad are being sampled before surgery for plasma as well as peripheral blood cells. after surgery patients are being sampled again at 24 h and 7 days. inflammatory response is being monitored on gene expression as well as cell level and on cytokine level in relation to the outcome.

Eligibility criteria:
inclusion criteria: 1. subject is ≥ 18 years of age 2. subject is treated with a vad at the butterworth campus, spectrum health. exclusion criteria: 1. subject is less than 18 years of age. 2. known prisoners of the state. 3. subject is pregnant. 4. non- english speaking patients will be excluded from the blood sub-study

Keywords: ventricular assist device
safety and performance study of the electroencephalographic recording device and sound emissions

Conditions: Sleep Disorder

Summary: safety and performance study of the memowave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment

24 subjects aged between 40 and 85 years, presenting a mild cognitive disorder of the amnesic type (ie a memory complaint, a mini mental state ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall of the rlri16 test) will be included; each patient spends 3 polysomnography nights at hospital: 1 night of habituation without memowave device and next 2 nights with memovave. the device emits sounds to increase slow brain waves but memowave emits sounds during only one of the two nights of test (night placebo vs night "verum"). the attribution of the night is randomized.

Eligibility criteria:
inclusion criteria: * subject presenting a mild cognitive disorder of the amnesic type, defined by a memory complaint, a mini mental state ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall) of the rlri16 episodic verbal memory test * at least 7 years of schooling exclusion criteria: * severe psychiatric pathology * known neurological pathology * high risk of apnea syndrome defined by at least 2 positive categories (each with a score ≥2) on the berlin questionnaire for apnea syndrome screening * high risk of behavioral disorder in rem sleep defined by an rbdsq score\> 5. * taking sleeping pills or antidepressants * severe heart disease or unbalanced diabetes
assessment of ovarian reserve in female cancer survivors

Conditions: Breast Cancer Survivor; Pediatric Cancer Survivor

Summary: chemotherapy can damage the ovaries and cause premature menopause. in women treated before the age of 40 years, menopause does not usually occur. we have very little information about the impact of chemotherapy on ovarian function in this particular group of women. in this study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and childhood cancer. we will do the same tests in our comparison group. we can use these results to estimate the reduction in fertility in young cancer survivors.

as women across north america and europe increasingly delay childbirth, fertility preservation is emerging as an important issue among young breast cancer patients. the dramatic increase in survival for the major pediatric cancers in the last 50 years has resulted in an expanding population of childhood cancer survivors. the information currently available to counsel these patients about the impact of treatment on their fertility is inadequate. a significant degree of subfertility can exist prior to the onset of frank ovarian failure, and current studies do not address this. this study will adopt new technologies that have revolutionized the evaluation of female fertility to assess ovarian function in young breast cancer survivors. the results will provide new, more accurate and clinically useful information to patients and physicians about the impact of cancer therapy on fertility. the results have the potential to influence clinical decisions regarding cancer treatment, and the use of assisted reproductive technologies for contemporary patients and survivors. further, insofar as treatment advances are designed to improve disease control while reducing toxicity, these results may serve as the basis for better understanding the toxicity of modern therapy and provide opportunities for improvement.

Eligibility criteria:
inclusion criteria: * breast cancer survivors 1. histological confirmation of breast cancer 2. received chemotherapy +/- radiotherapy with curative intent 3. age 40 years or less at the time of diagnosis 4. currently age 50 years or less 5. currently disease free. * pediatric cancer survivors 1. received chemotherapy and / or radiotherapy with curative intent. 2. currently age 18 years and older. 3. currently premenopausal and attained at age 50 years or less. 4. currently disease free. 5. diagnosed with sarcoma or hodgkin's disease or leukemia at 30 years or less. * control group 1. premenopausal. exclusion criteria: * breast cancer survivors 1. treatment for malignancy other than breast cancer, involving chemotherapy or radiation to the ovaries/pelvis. 2. any cancer recurrence 3. hysterectomy/oophorectomy. * pediatric cancer survivors 1. hysterectomy / oophorectomy. 2. pelvic radiation. * control group 1. received chemotherapy and / or pelvic radiation therapy, 2. hysterectomy/oophorectomy.
welch emotional connection screen (wecs) in the nicu

Conditions: Premature Birth; Obstetric Labor, Premature

Summary: the purpose of this study is to assess knowledge about emotional connection, attitude about relational health, and efficacy of welch emotional connection screen (wecs) training in the nicu. the investigators seek to discern if through this didactic training, frontline nicu clinicians can be taught to reliably use the wecs to rate parent-child relational health. additionally, the investigators seek to learn if there is construct and theoretical validity of the hospitalized infant preterm wecs by correlating wecs scores to physiological, behavioral and mental health markers for parent and infant.

the welch emotional connection screen (wecs) is an investigational developmental screening tool that was developed to rate the quality of the emotional connection that formed between mother and child. when administered at 4 months of age, the scale has predictive value in determining which children will show higher risk for developmental problems at 18 months of age. the scale is administered in 2-3 minutes by observing a brief interaction between mother and child and requires the rater to critically assess 4 domains of emotional connection. the present study will introduce an educational module for teaching nicu clinicians to critically observe mother-child interactions through use of a standardized didactic experience and structured use of the brief clinical screening tool, the wecs, and the theories around nurturing and emotional connection. in one module training session, participants will view a pre-recorded webinar on the wecs developed by the nurture science program at columbia university. during the second part of the training, participants will view and rate a set of pre-recorded parent-child interactions using the wecs. clinicians will complete a survey and participate in a focus group discussion about their experiences with the training process and utility of the wecs in clinical practice. determining if the wecs can be used easily and reliably by nicu clinicians will help to create new strategies that better meet the needs of all professionals involved in nicu care, as well as the families they serve.

Eligibility criteria:
inclusion criteria: * population 1: consenting interdisciplinary professional clinical staff who are employed to work in the nicu as a: * nurse * therapist * social worker * physician * population 2: consenting parents and infants whose parents give consent by guardianship and whose physicians approve inclusion in the study. exclusion criteria: * both populations: refusal to consent

Keywords: nursing education emotional connection
targeted antimalarial drug administration for seasonal migrant populations in amhara region, ethiopia

Conditions: Plasmodium Falciparum; Malaria

Summary: the purpose of the study is to assess the effectiveness, feasibility, and acceptability of targeted drug administration for seasonal migrant populations in metema district, amhara region, ethiopia

a cluster randomized controlled trial will be used to evaluate the effectiveness, feasibility, and acceptability of targeted antimalarial drug administration (tda) for seasonal migrant farmworkers in the delello farm sites in metema district, amhara region. individual farm sites will be randomized 1:1:1 to either of two intervention options or control, where all farmworkers at intervention sites will receive either two or three rounds of dihydro artemisinin piperaquine over the primary farming season. all study farm-sites will receive enhanced case management conducted by mobile health teams throughout the study period. cross-sectional surveys will be conducted in all arms at baseline and 4 to 6 weeks following the third round of tda to assess the effectiveness of the intervention for reducing parasite prevalence.

Eligibility criteria:
inclusion criteria: * at the time of the study, be a seasonal farm worker at one of the selected farm sites in metema district * available and willingness to participate in the study and provide consent (or parental/guardian consent and asset in the case of minors) exclusion criteria: * severe illness (will be referred for care) * inability to provide informed consent * age 14-17 years old and not having a parent/guardian at the farm who can provide consent * age \<14 years old additional exclusion criteria for the intervention group: * having received an antimalarial drug within the last 2 weeks * having any of the contraindications to receiving dp: * history of cardiac rhythm disturbances, bradycardia, or heart failure * concomitant treatment with drugs that prolong the qt interval (fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron, etc.) or drugs containing any of the following: flecainide, metoprolol, imipramine, amitriptyline, clomipramine * known allergic reactions to dp or other artemisinin derivatives * pregnancy
benefits of digital dance game by older adults

Conditions: Aged

Summary: this study aims to examine the clinical efficacy of dancing somatosensory videogames in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, mri) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.

this randomized controlled trial followed the consort guidelines to compare the clinical efficacy of the intervention group with the control group. the intervention group and control group were randomly allocated (1:1) with no stratification. the intervention group received the dance somatosensory videogame (dsg) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. the control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period. the primary outcome of the trial was changes of gray matter volume of the brain done by 3t brain magnetic resonance imaging during the study period. the secondary outcomes included cognitive performance, quality of life, physical activities, resilience, and demoralization. for all outcome variables, the measurements at the baseline and 6-month follow-up were examined by a random intercept and a fixed slope, and the effect of the intervention was estimated by using the generalized estimating equation.

Eligibility criteria:
inclusion criteria: 1. age ≥ 55 years old. 2. more than 6 years of formal education. 3. can communicate in mandarin and taiwanese. 4. can accept mri examination without claustrophobia. 5. can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject. exclusion criteria: 1. have engaged in any video dancing games in the past three months. 2. engaged in video dancing games more than three times per year in the past three years.

Keywords: digital dance game older adults brain gray matter volume cognitive performance
vitamin d supplementation in cad and postchallenge hyperglycemia

Conditions: Coronary Artery Disease; Postprandial Hyperglycemia; Vitamin D Deficiency

Summary: the main aim of the investigation is to clarify, whether vitamin d supplementation in coronary artery disease patients with vitamin d deficiency and postchallenge hyperglycemia has an impact on endothelial dysfunction and parameters of insulin sensitivity and beta-cell function.

an improvement of endothelial dysfunction as a cardiovascular surrogate parameter could be translated in a reduced risk for future cardiovascular events, which is of major interest, since patients with postchallenge hyperglycemia face a significantly higher cardiovascular risk than patients with normal glucose tolerance. furthermore an improvement in insulin sensitivity and/or beta-cell function would identify vitamin d as an important strategy for the prevention of type 2 diabetes. in consideration of the rapidly increasing prevalence of diabetes and the failure of current prevention strategies this could be an important, safe and cheap way to support ongoing lifestyle modifying programs. our study of course investigates surrogate cardiovascular and insulin sensitivity parameters. assuming a beneficial effect of vitamin d in our study, this concept would have to be proven in further large outcome as well as diabetes prevention trials.

Eligibility criteria:
inclusion criteria: * age 40-75 * postchallenge hyperglycemia (2h-whole blood glucose value in oral glucose tolerance test above 119 mg/dl, normal fasting glucose) * angiographically verified coronary artery disease (\>50% stenosis) * serum 25-oh- vitamin d \< 20 ng/ml in winter/spring/autumn and \<25 ng/ml during june-september * stable antihypertensive therapy in the last 3 month exclusion criteria: * acute coronary syndrome or cerebrovascular event within the previous 1 month * bmi \> 40 kg/m² * serum creatinine \>2.5 times the upper limit of normal * got or gpt \> 3 times the upper limit of normal * heart failure \> nyha class ii * uncontrolled hypertension (\>160/100 mmhg) * new onset of statins, ace-inhibitors or arbs within the previous 4 weeks * history of urolithiasis * hypercalcaemia * major psychiatric disorders * ongoing treatment with spironolactone, canrenoate, eplerenone, amiloride, triamterene and aliskiren. * treatment with antipsychotic drugs * regular significant antioxidants, vitamins or protein supplementation * immunosuppressive therapy * glucocorticoid therapy * ongoing chemotherapy * pregnancy * any other disease with an estimated life expectancy below 1 year.

Keywords: endothelial function insulin sensitivity
circulating tumor cells to guide chemotherapy for metastatic breast cancer

Conditions: Breast Cancer Ductal Infiltrating Metastatic

Summary: evaluation of the use of circulating tumour cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

phase iii multicentre, randomized, open-label study comparing early evaluation of the efficacy of chemotherapy by determination of circulating tumour cells versus conventional clinical and radiological evaluation.

Eligibility criteria:
inclusion criteria: * women over the age of 18 years. * who performance status: 0 to 4. * metastatic breast cancer. * progression after 2 lines of chemotherapy with decision to initiate third-line chemotherapy. * disease evaluable by ctc (ctc-positive before starting chemotherapy). * histology: lobular or ductal adenocarcinoma. * information of the patient and signature of the informed consent form by the patient or her legal representative. exclusion criteria: * disease not evaluable by ctc (ctc-negative before starting chemotherapy). * history of other potentially metastatic cancer (stage iii or iv cancer) different from breast cancer. * histology other than lobular or ductal adenocarcinoma. * pregnant woman, women likely to become pregnant or nursing mothers. * persons deprived of their freedom or under guardianship. * women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.